Cardiac Resynchronization TherapyREVERTNCT01302470
Comparison of Epicardial Versus Conventional Lead Placement in Cardiac Resynchronization Therapy
A study testing Primary epicardial placement of left ventricular lead and Transvenous placement of left ventricular lead in people with Cardiac Resynchronization Therapy and Heart Failure, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
The primary goal of this study is to evaluate the use of robotically -assisted device leads as a primary strategy for heart resynchronization.This trials aims to compare transvenous lead placement with robotic lead placement for cardiac resynchronization therapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiac Resynchronization Therapy, Heart Failure
- What is being tested?
- Primary epicardial placement of left ventricular lead and Transvenous placement of left ventricular lead
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic NYHA class III or IV heart failure from idiopathic or ischemic heart failure
- QRS interval greater than or equal to 130 msec
- Left ventricular end diastolic diameter greater than or equal to 55 mm
- left ventricular ejection fraction less than or equal to 35
- Willingness to participate
Who cannot join
- Acute renal failure; active GI bleeding; unexplained fever which may be due to an infection
- untreated active infection
- acute stroke
- severe uncontrolled systemic hypertension
- severe systemic electrolyte imbalance
- severe concomitant illness that drastically shortens life expectancy
Show all 12Show fewer
- severe coagulopathy
- history of severe COPD and inability to tolerate single lung ventilation
- History of prior left sided thoracotomy
- history of recent intravenous drug use
- concomitant psychiatric diagnosis that impairs patient's ability to comply with study protocol
- participation in another investigational protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
St.Lukes-Roosevelt Hospital
New York, New York, 10025
About this study
Official title: Randomized Study of Endovascular Versus Epicardial Lead Placement for Resynchronization Therapy
The primary goal of this study is to evaluate the use of robotically -assisted device leads as a primary strategy for heart resynchronization.This trials aims to compare transvenous lead placement with robotic lead placement for cardiac resynchronization therapy.
Read the detailed description
A secondary goal is to explore the link between efficacy of CRT and inotropic contractile reserve as measured by dobutamine stress echocardiography.
- Conditions
- Cardiac Resynchronization Therapy, Heart Failure
- Being tested
- Primary epicardial placement of left ventricular lead, Transvenous placement of left ventricular lead
- Keywords
- biventricular pacing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary epicardial placement of left ventricular leadProcedure or surgery
Also called cardiac resynchronization therapy
Epicardial leads will be placed on the left ventricle in the area of the most dyssynchrony . the leads will be attached to a Medtronic Cardiac resynchronization/ AICD/ device
Transvenous placement of left ventricular leadProcedure or surgery
Also called Cardiac resynchronization Therapy, CRT/ AICD
Conventional placement of left ventricular leads performed in the electrophysiology department.
| Study group | Role | What they receive |
|---|---|---|
| Robotic placement of CS lead | Active comparator | CS leads placed epicardially in the area of increased dyssynchrony as demonstrated by low dose dobutamine stress testing. Receives: Procedure: Primary epicardial placement of left ventricular lead |
| Transvenous placement of CS lead | Active comparator | CS lead will be placed transvenously Receives: Procedure: Transvenous placement of left ventricular lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
CHF Hospitalizations & mortality
Heart failure and mortality will be assesd along with six minute hall walk tests
Measured: one year post implant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startFeb 2005
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Resynchronization TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Collaborators
- Montefiore Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302470
- Sponsor's protocol ID
- 04-052
- Acronym
- REVERT
- Status last verified
- Feb 2015
- First submitted
- 18 Feb 2011
- Last updated
- 19 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Endovascular Versus Epicardial Lead Placement for Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT01302470
- Acronym / sponsor ID
- REVERT / 04-052
- Conditions
- Cardiac Resynchronization Therapy, Heart Failure
- Keywords
- biventricular pacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Collaborators
- Montefiore Medical Center
- Study start
- Feb 2005
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of this study is to evaluate the use of robotically -assisted device leads as a primary strategy for heart resynchronization.This trials aims to compare transvenous lead placement with robotic lead placement for cardiac resynchronization therapy.
Detailed description
A secondary goal is to explore the link between efficacy of CRT and inotropic contractile reserve as measured by dobutamine stress echocardiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic placement of CS lead | Active comparator | Procedure: Primary epicardial placement of left ventricular leadCS leads placed epicardially in the area of increased dyssynchrony as demonstrated by low dose dobutamine stress testing. |
| Transvenous placement of CS lead | Active comparator | Procedure: Transvenous placement of left ventricular leadCS lead will be placed transvenously |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Symptomatic NYHA class III or IV heart failure from idiopathic or ischemic heart failure
- QRS interval greater than or equal to 130 msec
- Left ventricular end diastolic diameter greater than or equal to 55 mm
- left ventricular ejection fraction less than or equal to 35
- Willingness to participate
Key exclusion criteria (12 listed)
- Acute renal failure; active GI bleeding; unexplained fever which may be due to an infection
- untreated active infection
- acute stroke
- severe uncontrolled systemic hypertension
- severe systemic electrolyte imbalance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary epicardial placement of left ventricular leadAlso: cardiac resynchronization therapyEpicardial leads will be placed on the left ventricle in the area of the most dyssynchrony . the leads will be attached to a Medtronic Cardiac resynchronization/ AICD/ device | Procedure or surgery | Robotic placement of CS lead |
| Transvenous placement of left ventricular leadAlso: Cardiac resynchronization Therapy, CRT/ AICDConventional placement of left ventricular leads performed in the electrophysiology department. | Procedure or surgery | Transvenous placement of CS lead |
Primary outcome
CHF Hospitalizations & mortality
Time frame: one year post implant.
Heart failure and mortality will be assesd along with six minute hall walk tests
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary epicardial placement of left ventricular lead and Transvenous placement of left ventricular lead in people with Cardiac Resynchronization Therapy and Heart Failure, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CHF Hospitalizations & mortality (time frame: one year post implant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2015.